The Spanish notified body (NB) said Thursday it will no longer accept new medical device applications from new clients for CE marking per 92/42/EEC beginning 1 June 2019 and cease to process new certificate applications from existing clients from 31 July 2019.
The Spanish Agency of Medicines and Medical Products (AEMPS), acting as NB 0318 under the EU’s medical device directive, did not offer any concrete explanation for its decision to retire CE marking operations. It merely cited the need for ensuring that all new evaluations, which can take up to a year to complete, are completed per 92/42/EEC prior to 26 May 2020. It did, however, issue a new brochure
in a Q&A format for certain clarifications on next steps.
Questions AEMPS answers in the new brochure offer considerations for manufacturers, including those that are not current clients, around CE marking. Considerations range from new certifications to applying for certificate extension.
Still, the decision adds to the pile of uncertainty and turmoil in the EU that has largely been driven by the lack of NBs designated against the medical device regulation (MDR). Whether NB 0318 will be designated per EU MDR 2017/745—otherwise known as MDR—to continue their CE marking operations also remains unclear.
CEO and founder of UK-based MedBoard Ivan Perez told Focus
that “the news from Spain is unfortunately very bad.” He argues that “all medical device manufacturers” with Spain’s NB “may be left in limbo” since it has not been MDR designated. "Some manufacturers have already transferred to other NBs or are now considering it very seriously."
“I cannot imagine the dramatic consequences for manufacturers, in terms of product development, business, resources and financial planning, and more important, to patients,” Perez said. "More certainty and stability for businesses" is required "to allow them to focus on solutions to patients."
The European Commission (EC) has sought
to ease industry concerns around NB availability, among several other issues, as it rushes to complete the transition by the 26 May 2020 date of application.
Medical device industry groups in the EU have continued
to urge the EC and member states to provide some relief, especially since only two NBs
have been designated against MDR so far.